Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)

Active
Yes
Status
Posted
Published Date
April 3rd, 2024
Close Date
October 18th, 2024
Opportunity No.
RFA-MH-25-190

Agency

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The National Institutes of Health is offering a federal grant opportunity titled "Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)". This grant aims to support the development and validation of predictive tools and/or biomarkers that can inform individual-level treatment selection for depression. The grant will be provided in two phases, UG3 and UH3, and will involve multi-disciplinary teams addressing scientific, technical, clinical, regulatory, and commercialization requirements. In the UG3 phase, investigators are expected to identify potential tools and/or biomarkers that can predict differential response to different depression treatments. In the UH3 phase, independent clinical trials will be conducted to validate the utility of the identified tools/biomarkers. The overall goal of this grant is to test and evaluate various tools/biomarkers as predictors of response to established depression treatments. For more information and to apply, visit the following link: Precision Mental Health Grant.

Description

The purpose of this phased Notice of Funding Opportunity (NOFO) is to create a pipeline to accelerate the development and early validation of predictive tools and/or biomarkers to inform individual-level treatment selection among two or more existing therapeutics for depression. This phased inter-agency program will be milestone-based and provide support from multi-disciplinary teams to address scientific, technical, clinical, regulatory, and commercialization requirements. In the first phase (UG3), investigators are expected to identify potential tools and/or biomarker(s) that can predict whether a patient will differentially respond to one well-established depression treatment versus another. This could be accomplished using secondary analysis of data from completed clinical trials or using real-world clinical data, or by conducting small, efficient pilot feasibility studies to assess promising new tools or biomarkers to predict individual treatment response to a specific therapeutic for depression. In the second phase (UH3), investigators will conduct independent, prospective clinical trials to initially validate the utility of the tool/biomarker for predicting differential response to established treatments for depression. The overall goal of this NOFO is to support the testing of various tools/biomarkers as predictors of response to well-established depression treatments and halt the development of those tools that do not meet sufficient performance characteristics to justify further testing. Ultimately, tools that are successful in early-stage studies could be further evaluated for future use in decision-making in clinical practice settings.

Contact Information

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